MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) OPTICROSS?; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749518080

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.During a percutaneous coronary intervention an opticross¿ was used to diagnose a moderately calcified and moderately tortuous lesion located at the proximal end of the left circumflex artery with 90 percent stenosis.The shaft of this device was kinked inside the patient.The procedure was completed with another with same device.No patient complications reported and the patient's condition is good.However, device analysis revealed the clear imaging window detached from the blue sheath tubing at lap joint seam.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The complaint device was received for evaluation.Evaluation of the returned device revealed that the catheter was received with the clear imaging window detached from the blue sheath tubing at lap joint seam.This exposes the imaging core.Water was leaking from the blue sheath tubing at the detached lap joint section during the flushing process.The telescope assembly was not able to properly pullback or advance due to the detached imaging window.Impedance testing finds that there was no electrical disconnect in the imaging circuit.Full image characterization cannot be performed due to the imaging window detached from the blue sheath tubing at the lap joint seam.The detachment exposes the imaging core which might onset a windup of the imaging core when a functional test is performed.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: OPTICROSS?
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3952464
• MDR Text Key: 4641529
• Report Number: 2134265-2014-04296
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: K123621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16766810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1